FDA pushes for non-opioid pain medications

Agency aims to spur drugmakers to develop new products

Bloomberg
Scott Gottlieb, commissioner of the Food and Drug Administration, listens during a hearing in Washington, D.C., earlier this year.

Washington Post

The Food and Drug Administration plans steps to encourage the development of non-addictive alternatives to opioid pain medications, Commissioner Scott Gottlieb said.

As part of the effort, the agency plans to withdraw its existing 2014 guidance to the drug industry on pain medicines. That document is overly broad, Gottlieb said, and is sometimes a barrier to new products and innovations.

The current guidelines call for a large number of studies to get FDA approval for general use for chronic pain, he added.

Over the next six to 12 months, the agency plans to issue several documents intended to spur development of medications for specific types of pain.

The result should lead to smaller clinical trials, faster approvals and quicker launches of novel therapies, Gottlieb said.

One of the advisories will provide drug companies information on what the FDA is looking for in non-opioid medications for chronic pain, while another will detail how manufacturers can show that their product reduces patients’ exposure to opioids for acute pain.

Yet another will update drugmakers on how they should assess the risks of illicit use of their drugs, a factor in FDA reviews of drugs.

The move is the latest of varied FDA efforts to combat the opioid epidemic, which Gottlieb repeatedly has said is a top agency priority.

On Tuesday, for example, the agency sent warning letters to four online networks operating 21 websites that illegally market unapproved medications.

It directed the networks to immediately stop selling the products.

Other FDA officials say they hope that new road maps for bringing non-opioid pain medications to market will encourage drug companies to focus more intently on the field.

And overall, they say, the drug industry is moving toward more-targeted therapies and away from the broad use of medications.

The Centers for Disease Control and Prevention has reported that prescriptions for opioids have declined somewhat in recent years, but a recent Mayo Clinic study found that opioid use over the past decade has not substantially decreased.

Washington Post

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